Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma

Exclusion Criteria

• •2. II (1.5 to 4 mm or level IV-T3N0M0-)-eligible
• •3. III (limited nodal metastasis involving one regional lymph node basin, or fewer than 5 in-transit metastasis -TxN1M0-)-eligible
• •4. IV (advanced regional metastasis -TxN2M0- or any distant metastasis -TxNxM1-)-eligible
• •5. Relapsed melanoma-eligible
• •Patients previously treated with any form of therapy for either metastatic, relapsed or primary melanoma are eligible for this trial, provided that previous treatment was completed \>30 days prior to enrollment
• •Both male and females may be enrolled. Premenopausal females must have a negative pregnancy test prior to treatment
• •Karnofsky Performance Status greater than or equal to 70 percent
• •No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease
• •No previous evidence of opportunistic infection
• •A minimum of 30 days must have elapsed since the completion of prior chemotherapy, immunotherapy or radiation therapy
• •Adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry (day -30 to 0):
• •1. Hemoglobin \>9.0 g/dl
• •2. Platelets \> 100000/mm3
• •3. WBC \> 3000/mm3
• •4. Absolute Neutrophil Count \> 1000/mm3
• •Positive skin test to common antigens (tetanus and candida)
• •Ability to give informed consent
• •Lactating females and females of child-bearing potential must have negative serum beta-HCG pregnancy test
• •Acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy. Acute therapy must have been completed within 14 days of prior to study treatment
• •HIV-infected patients
• •Acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk
• •Patients with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study)
• •Patients with organ allografts